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Presentation
to 4th year medical students at Salman University Kharj on May 21,
2013 by Professor Omar Hasan Kasule Sr.
1.0 HISTORICAL BACKGROUND
Early humans experimented with
several plants and by trial and error found some to be useful as medicines and
others to be poisonous. These early experiments were not planned in a
systematic way neither were they documented.
Galen founded experimental
medicine before 200 CE. Historical experiments were carried out by James Lind
In 1747 on scurvy, Dr Edward Jenner in 1798 on small pox, and Goldberger in
1914 on pellagra. Community trials were carried out on vitamin C, the Salk and
HBV vaccines, cardiac disease risk factors, and water fluoridation for dental
caries. Clinical trials were on streptomycin in TB 1948, aspirin and vitamin C
for cancer prevention, alpha-tocopherol and beta-carotene in lung cancer
prevention in smokers.
Unethical experiments without
informed consent were carried out in the 1940s, 1950s, and 1960s. The Nuremberg
code of 1946 laid down rules on voluntary informed consent, unnecessary
experiments, animal before human experimentation, physical and mental
suffering, scientific qualification of researchers, freedom of subjects to
withdraw, and stopping the investigation if patient are in danger.
The Helsinki Declaration of 1964
incorporated the Nurenberg code. Its basic principles were: conformity to generally
accepted scientific principles, qualified researchers, risk benefit assessment,
research subject welfare, and full disclosure before informed consent.
The Nuremberg and Helsinki codes
on experimentation did not stop all unethical research. They were neither laws
enforceable by the state nor moral standards enforced by conscience. They are
an unsuccessful attempt at bridging the secular divide between morality and
public life. New international conventions and national legislation have been
used to give legal effect to many ethical guidelines.
2.0 PURPOSES OF THE LAW IN HUMAN EXPERIMENTATION
The permissibility of human
research is based on the 5 purposes of the Law: morality, life, progeny, the
mind, and wealth. If any of those 5 necessities is at risk permission is given
to undertake human experiments that would otherwise be legally prohibited.
Therapeutic research fulfills the
purpose of protecting health and life. Infertility research fulfils the purpose
of protecting progeny. Psychiatric research fulfills the purpose of protecting
the mind. The search for cheaper treatments fulfills the purpose of protecting
wealth.
3.0 PRINCIPLES OF THE LAW IN HUMAN EXPERIMENTATION
Research is judged by its
underlying and not expressed intentions.
Research is prohibited if there
is no evidence to indicate that better treatment is likely to result.
Research is allowed if benefits
outweigh the risks or if public interest outweighs individual interest. If the
risk is equal to the benefit, prevention of risks from research has priority
over pursuit of a benefit of equal worth.
The Law chooses the lesser of the
two evils, injury due to disease or risk of experimentation.
The principle of custom is used
to define standards of good clinical practice as what the majority of
reasonable physicians consider as reasonable.
An existing treatment is
continued until there is evidence to the contrary.
A physician can ignore results of
a new experiment because of some inclination in his mind.
4.0 INFORMED CONSENT
Informed consent by a legally
competent research subject is mandatory. Informed consent does not legalize
risky non-therapeutic research with no potential benefit. It is illegal to
force participation of the weak (prisoners, children, the ignorant, mentally
incapacitated, and the poor) in clinical trials even if they sign informed
consent forms.
5.0 OUTSTANDING ETHICO-LEGAL ISSUES
Research on fetal human tissues
may encourage abortion.
Cadaver dissection and post
mortem examination are permitted under necessity.
Use of human bodies in auto crass
experiments violates human dignity.
Genetic experiments may cause
diseases hitherto unknown.
The Law allows research on ageing
as long as the aim is not prolongation of life or preventing death because
those aspects are under divine control.